Efficacy and Safety of Recombinant Factor VIII (GreenGene) in Patients With Hemophilia A

Hemophilia A Clinical Trial

Official title:

Open-label, Non-comparative, Multicenter, Phase III for Evaluation of Efficacy and Safety of Recombinant Factor VIII (GreenGene) in Previously Treated Patients With Hemophilia A

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01568580
• Other study ID #: GC8AIII
• Status: Completed
• Phase: Phase 3
• First received: March 22, 2012
• Last updated: March 29, 2012
• Start date: December 2004
• Est. completion date: September 2006

Study information

• Verified date: March 2012
• Source: Green Cross Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to study the evaluation of efficacy and safety of GreenGene (Recombinant Factor VIII).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 71
• Est. completion date: September 2006
• Est. primary completion date: September 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years and older

Eligibility

Inclusion Criteria:

• Hemophilia A patients at least 12 years of age

• At least 150 treatment exposure-days to previous FVIII products

• FVIII=2% at screening or diagnosis (FVIII=1% for PK study)

• CD4 Lympocyte cell count>400/?

• Patients willing to cooperate for the study

• Patient's or legal guardian's consent to participate in the study

Exclusion Criteria:

• FVIII inhibitor(neutralizing antibody to FVIII)=0.6 Bethesda Units

• Coagulation disorders other than hemophilia A (e.g. Idiopathic Thrombocytopenic Purpura, von Willebrand Disease)

• Platelet count=100,000?

• Subjects with clinical evidence of symptomatic HIV disease regardless of HIV-seroposive/seronegative

• Subjects with rFVIII antibody, mouse IgG antibody, or CHO antibody

• Creatinine levels more than 2 times of reference rage, GOT and GPT levels more than 3 times of reference range, diabetes mellitus or other metabolic disorder

• Subjects with diastolic blood pressure=100mmHg not controlled with antihypertensive medications

• Anemia(hemoglobin<12g/dL)

• Subjects with severe or life-threatening bleeding just before entry into the trial

• Subjects with a history of treatment failure due to formation of inhibitor to FVIII

• Subjects with a history of severe hypersensitive reactions to FVIII concentrate

• Subjects requiring pre-medication for FVIII infusion(e.g. antihistamines, etc)

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hemophilia A

Intervention

Drug:
• GreenGene
Dose : 10 ~ 50IU/kg Administration method : intravenous infusion or bolus

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Green Cross Corporation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Physician's assessment of hemostatic effect for on-demand treatment	Category: Exellent, Good, Moderate, None	12 months	No
Primary	Hemostatic effect for major bleeding	Category: Exellent, Good, Moderate, None	up to 1 year	No
Secondary	consumption amount of test drug		up to 12 month or 100 exposure days	No
Secondary	Subject's self assessment of treatment	Category: Exellent, Good, Moderate, None	12 months	No
Secondary	FVIII Recovery(%)		every 3 months	No
Secondary	FVIII inhibitor incidence rate		every 3 months	Yes
Secondary	The number of adverse events		up to 1 year	Yes
Secondary	Surgery study: prohylactic effects	Category: Exellent, Good, Moderate, None	up to 1 year	No